Application of ‘Readiness for Change’ concept within implementation of evidence-based mental health interventions globally: protocol for a scoping review

Background Concerning the growing burden of mental illnesses globally, there has been an increased investment into the implementation of evidence-based mental health interventions (EBmhIs) in routine care settings. However, the uptake and implementation of these EBmhIs has faced challenges in the real-world context. Among the many barriers and facilitators of implementation of EBmhIs identified by implementation science frameworks, evidence on the role of readiness for change (RFC) remains sparse. RFC constitutes the willingness and perceived capacity of stakeholders across an organization to implement a new practice. Theoretically, RFC has been defined at organizational, group, and individual levels, however, its conceptualization and operationalization across all these levels have differed in studies on the implementation of EBmhIs. By conducting a scoping review, we aim to examine the literature on RFC within the implementation of EBmhIs. Methods This scoping review will be conducted following the PRISMA-ScR guidelines. Iterative review stages will include a systematic and comprehensive search through four electronic databases (PubMed, Web of Science, Embase, and PsycINFO), selecting studies, charting data, and synthesizing the results. English-language studies meeting the inclusion criteria will be screened independently by two reviewers. Discussion This review will synthesize knowledge on the conceptualization of RFC across organizational, group, and individual levels within the implementation of EBmhIs. In addition, it will identify how RFC has been measured in these studies and summarize the reported evidence on its impact on the implementation of EBmhIs. Conclusions This review will assist mental health researchers, implementation scientists, and mental health care providers to gain a better understanding of the state of research on RFC within the implementation of EBmhIs. Registration The final protocol was registered with the Open Science Framework on October 21, 2022 ( https://osf.io/rs5n7).


Introduction
Globally, there is a growing burden of mental illnesses, especially in light of the COVID-19 pandemic, accounting for upto 16% of global disability-adjusted life years (DALYs; approximately 418 million DALYs) (Arias et al., 2022).The Global Burden of Diseases study in 2019 also indicated that since past few decades, mental illnesses have remained among the top ten leading causes of burden worldwide (Global Burden of Diseases (GBD) 2019 Mental Disorders Collaborators, 2022), pointing to stigma as well as limited availability of psychological treatments (Rehm & Shield, 2019).This high burden has not only had substantial impact on all areas of life for populations, but has also costed global economy about 7.2 trillion international dollars in 2019 (Arias et al., 2022).Moreover, the World Health Organization has advocated for the importance of mental health in the achievement of sustainable development goals (World Health Organization, 2019), emphasizing the role of mental health in overall health and well-being, encouraging economic productivity and reducing poverty, improving access to education and enhancing ability to learn, reducing violence and improving gender equality, among others (Dybdahl & Lien, 2017).
In response to this, increased attention is being paid to utilize the evidence-based mental health interventions (EBm-hIs), or psychological treatments and modes of mental health care services delivery that are supported by empirical evidence and research demonstrating their effectiveness, and translate them into practice to improve the mental health outcomes (Muñoz & Cooper, 2022;Safieh et al., 2022;World Health Organization, 2022).Considering a global point of view, testing and implementation of EBmhIs has been more prevalent in high-income countries (HICs) than in low-and middle-income countries (LMICs) (Ingleby, 2014;Ribeiro et al., 2023;Tiley & Kyriakopoulos, 2018).Notably, in all settings, the actual uptake and implementation of EBmhIs in routine care settings (Beidas et al., 2021;McHugh & Barlow, 2010;Shafran et al., 2009).And this has been particularly challenging for settings that are low in resources for mental health such as LMICs where there has been scant research on the applicability and sustainability of EBmhIs (that are mostly developed in HICs) (Ingleby, 2014;Rajabzadeh et al., 2021;Ribeiro et al., 2023;Tiley & Kyriakopoulos, 2018).Ultimately, the limited research and implementation has been associated with a range of factors such as lack of discussion of mental health in public health priority agenda, lack of political will, financial resources, and poor community participation, to name a few (Tiley & Kyriakopoulos, 2018).
The field of implementation science sheds further light on this 'know-do gap' by clarifying that the translation of clinical innovation into real-world settings is not spontaneous, is context-dependent, and needs methods and strategies to identify and address barriers and facilitators (Bauer & Kirchner, 2020).When an effective EBmhI is implemented in a routine care setting, it interacts with multiple setting-specific layers such as the healthcare policies, the culture and climate of the organization implementing it, and healthcare service providers and users (Proctor et al., 2009).It then becomes imperative to give these underlying interactions adequate thought, so that optimal performance of the EBmhI and favorable outcomes may be expected (Stirman et al., 2016).For example, in the context of lack of mental health professionals, large caseloads among those providing mental health care may lead to burnout or decreased quality of care (Le et al., 2022).
In the last three decades, several implementation science frameworks have been developed to guide step-by-step implementation of EBmhIs and identify the barriers and facilitators of the implementation process in the context where they are being implemented (Tabak et al., 2012;Villalobos Dintrans et al., 2019).These frameworks span across multiple levels of Bronfenbrenner's socioecological framework (Bronfenbrenner & Morris, 1998) and posit that implementation of EBmhIs is influenced by multi-level factors (Tabak et al., 2012;Villalobos Dintrans et al., 2019).Table 1 lists some examples at multiple levels that have been reported to influence implementation.
Notably, what remains sparse is a focus on readiness for change (RFC), which cuts across multiple levels and represents a complex interaction between these levels, as we explain below.
RFC constitutes the willingness and perceived capacity of stakeholders across an organization to implement a new practice (Holt & Vardaman, 2013;Rafferty et al., 2012;Vax et al., 2021).Readiness for change has been conceptualized at multiple levels-at the individual level, group level, and organizational level (Vakola, 2013).Individual RFC can be defined as "the extent to which an individual or individuals are cognitively and emotionally inclined to accept, embrace, and adopt a particular plan to purposefully alter the status quo" (Holt et al., 2007).Individual RFC as defined here differs from the readiness for

Amendments from Version 1
The revised scoping review protocol incorporates key enhancements based on valuable feedback from reviewers.The objectives and research questions were refined to explicitly state that we aim to assess the reported impact of RFC on implementation outcomes in our third research question.In response to concerns about the search strategy, we explained the limitation in including related terms due to an overwhelming volume of results.The discussion section now clearly outlines our intention to identify and provide a rationale for measuring readiness for change at different levels.The eligibility criteria and rationale for excluding grey literature were detailed further.We incorporated the Population, Concept, Context (PCC) framework, added a discussion on expected strengths and limitations, and corrected formatting issues.Additional background information on the global burden of mental illnesses and disparities in implementation across countries was included.Overall, these changes aim to enhance the clarity, comprehensiveness, and methodological rigor of the scoping review.
Any further responses from the reviewers can be found at the end of the article change in relation to health behaviors such as physical activity, diet, and smoking.Although both approaches draw from larger theories that explains behavior change (Prochaska & Velicer, 1997; Rogers, 1962), the latter focuses on adoption of healthy behaviors, while the former applies to changes in the context of implementation of evidence-based interventions.Further, group RFC acknowledges that an individual may identify with a group within an organization such as front line workers, supervisors, or administrators.Group RFC is based on the collective perceptions and beliefs of a group that a change is needed and beneficial, and that the group and the organization have the capacity to carry out the change requirements successfully (Vakola, 2013).Lastly, organizational RFC refers to macro-level factors such as organizational structure and culture, availability of resources, and leadership commitment that encourages or disrupts change (Vakola, 2013).Ultimately, when organizational readiness is high, it exerts a favorable influence on implementation of interventions via organization members' inclination to change, exert greater effort, and cooperate with others (Weiner, 2009) (Weiner et al., 2008).This review specifically focuses on the implementation of EBmhIs and profiles the various levels at which readiness for change has been conceptualized.

Objectives
We propose to conduct a scoping review to systematically search, review, and synthesize the available evidence on the conceptualization and operationalization of RFC within the implementation of EBmhIs globally.In addition, we will also examine the reported impact of RFC on implementation of EBmhIs.
The key research questions pursued for this scoping review are: 1.How has RFC been conceptualized within the implementation of EBmhIs globally?2. How has RFC been operationalized/measured within the implementation of EBmhIs globally?
3. What has been the reported impact of individual-, group-, and organizational-level RFC on the implementation of EBmhIs (particularly, how RFC influences key implementation outcomes such as adoption, feasibility, fidelity, and sustainability of EBmhIs)?

Methodology
This scoping review will be guided by the current protocol, which has been prepared based on the methodology and reporting guidelines presented in the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) (Tricco et al., 2018).
The key aspects of the review protocol are presented in this section.

Protocol and registration
The final protocol was registered with the Open Science Framework on October 21, 2022 (https://osf.io/rs5n7).

Eligibility criteria
Study designs.Randomized controlled trials, cohort studies, case-control studies, cross-sectional studies, case series, case reports, systematic reviews, and non-systematic/narrative reviews will be included.
Letters to editors, commentaries, theoretical articles, conference presentations, and chapters in textbook will be excluded.Typically, these articles serve a different purpose than those outlining empirical studies, and do not lend themselves to analysis that would align with our research questions.
Population.We will include studies involving human subjects of any age.There will be no limitations on the specific characteristics or demographics of the participants.
Concept.We will include studies assessing the implementation of evidence-based pharmacological, psychological, psycho-social, or mind-body interventions for any mental illness.
There will be no limitations related to the type, duration, frequency, or delivery setting of the interventions (community, school, institution, etc.).
Context.There will be no limitations on the context of the studies, and interventions delivered in various settings (community, school, institution, etc.) will be eligible for inclusion.
Timing.No limit will be set for timing of outcome assessments.
Setting.There will be no restrictions by the type of setting.We will include studies from all geographical areas.
Language.We will include articles reported in English language.A list of possibly relevant titles in other languages will be provided as an appendix.

Information sources
The following databases will be searched: PubMed, Embase, Web of Science, and PsycINFO.Only published literature will be searched, and the literature search will be limited to the English language and human subjects.Additionally, to ensure literature saturation, forward and backward searches of included studies will be carried out, along with the advanced search in Google Scholar.We will exclude grey literature from our search given the wide range of sources it encompasses and in our attempt to prioritize peer-reviewed studies that have undergone critical assessment.We will limit our search to articles published until November 2022.

Search strategy
The specific search strategies will be designed with the help of a librarian with expertise in searches for scoping review.First, strategy for PubMed will be developed by the research team and the librarian, and then peer reviewed by a second librarian, not otherwise associated with the project.Once the PubMed strategy is finalized, it will be adapted to the syntax and subject headings of the other databases.

Data management
Literature search results from all databases will be uploaded to Endnote for data management (i.e., removing duplicates, referencing, etc.).They will be later exported to Rayyan software for title and abstract screening.Articles will be included if they meet our eligibility criteria.

Selection process
Title and abstract screening will be done by an independent reviewers to select studies focused on implementation of evidence-based mental health interventions.Initially, ~50 titles will be utilized by SD and a research assistant (RA) to practice applying the eligibility criteria, and discrepancies will be identified and resolve.Next, 10% of the titles will be screened independently by both SD and the RA, to calculate inter-rater reliability using Cohen's Kappa.Any disagreements between the reviewers will be resolved by discussion or by including RS if no consensus can be obtained.Once an acceptable value of Cohen's Kappa is obtained (>80%), the rest of the titles will be randomly divided into two sets that will be screened by SD and RA individually.Full-text screening of the included titles will be done by the RA.Full text studies that do not meet the eligibility criteria will be excluded and reasons for their exclusions will be documented in the final report.This process will be tracked using a flow diagram, as outlined in the PRISMA-ScR guidelines (Page et al., 2021), which we have modified in Figure 1 to visually depict our selection process.

Data charting process
A data extraction sheet will be used by the independent reviewer to extract relevant information from the included studies.Following fields will be used to chart the data: author and date, title of the study, aim, study setting, study population, target mental illness, EBmhI utilized, level of conceptualization of readiness for change, definition of readiness for change, measure used for readiness for change, outcome, and comments.
In case data is insufficient or unavailable, the authors of the studies may be contacted for clarification.

Synthesis of results
A narrative report will be developed to summarize the extracted data around the kinds of EBmhIs, how readiness for change has been conceptualized, how it has been operationalized/measured, and its impact on the implementation of the EBmhIs.In addition, we will identify gaps in research in relation to readiness for change in implementation of EBmhIs that can be bridged by future research.

Study status
Search terms for all the databases are finalized and we plan to perform the database search once the protocol is published.

Discussion
RFC may be a crucial implementation factor for EBmhIs.There exists a strong theoretical foundation that explains the importance of RFC, and its existence at individual, group, and organizational levels (Vakola, 2013).Yet, it is unclear how studies on the implementation of EBmhIs conceptualize, operationalize, and measure RFC.Moreover, the evidence pool for the association of RFC with implementation outcomes is sparse.The proposed scoping review aims to synthesize knowledge to fill these gaps and inform research design, and help shape potential interventions to build RFC at multiple levels.We will note consistencies and inconsistencies in terminologies and conceptualization of RFC, how it has been measured and the psychometric properties of the assessment scales used, and the reported role of RFC on implementation of EBmhIs.
Our findings will highlight the extent to which implementation studies have conceptualized RFC at individual, group, and organizational levels.Considering the significance of RFC in the realm of implementation science (Vakola, 2013), we posit that ideally, it is beneficial to measure RFC at all three levels in the studies of EBmhI implementation.However, we do acknowledge that not every setting globally may have the resources available for such a scale of RFC measurement.Based on the evidence gathered to address our third research question regarding the influence of RFC on the implementation of EBmhIs, our review aims to identify and provide a rationale for the key levels at which RFC should be measured, depending on the specific setting.These findings will guide research designs to adequately conceptualize and measure RFC within the implementation of EBmhIs.
Finally, this scoping review will be pivotal for both research and practice.With this review, we aim to generate knowledge and evidence around the role of individual-and group-level RFC as well so as to build the foundation for the incorporation and integration of all levels of RFC in CFIR and other implementation science frameworks.In addition, by synthesizing knowledge around the measurement of the various levels of RFC, the results may serve as a resource to future studies aimed at developing or adapting and testing measurement instruments.This will further help health services researchers in investigating RFC as a determinant of implementation outcomes, and testing potential interventions to develop, nurture, and sustain RFC at various levels.

Expected Strengths and Limitations
To the best of our knowledge, this will be the first scoping review examining readiness for change within the implementation of EBmhIs globally.The results we report would need to be considered in light of certain limitations.First, readiness for change has been subject to the jingle fallacy i.e., many different terms has been used to refer to the same concept (for example, preparedness, willingness, commitment, openness, etc.) (Miake-Lye et al., 2020).However, our initial attempt to include such related terms in our search strategy led to a number of results that were unmanageable.Hence, we may have missed relevant studies in an attempt to focus our search strategy.Furthermore, we did not conduct a search of gray literature, and as such, the conclusions we'll draw are limited in generalizability.Finally, the inclusion of studies published in English may also limit the generalizability of the results we report.

Implications for Future Research
Overall, this scoping review may also hold potential to guide future research.By highlighting the varying conceptualizations as well as operationalization of RFC, future studies could advocate for and use consistent, unified framework for RFC in the context of implementing EBmhIs.This could involve synthesizing existing definitions and developing a more standardized way to measure RFC across different levels.In the longer term, such would also enhance the feasibility of conducting comprehensive systematic reviews and meta-analyses.In addition, this review could also motivate longitudinal studies to provide insights into the dynamic nature of readiness, identifying how readiness might impact implementation success.
Overall this is worthwhile study to map RFC to IR concepts.The research question is clear and the study methodology is sound.Some suggestions here offered: Consider whether it might be feasible to review grey literature, even in a small selection of countries.I imagine many of these implementation considerations may not be published in the peer reviewed literature, but rather sit within implementers manuals or local monitoring reports.Even a deep dive in a few countries may provide a useful contribution to scoping.

1.
Mental health interventions are a broad group, and wonder if it might be sensible to narrow down to a more manageable category.For example: MH interventions for children, or those delivered only in primary care settings.

2.
The publication dates for eligible papers is not defined and should ideally be included in the methodology.

3.
Is the rationale for, and objectives of, the study clearly described?Yes

Are sufficient details of the methods provided to allow replication by others? Yes
Are the datasets clearly presented in a useable and accessible format?Yes and to identify the barriers and facilitators within specific implementation contexts.To provide more examples of factors that enable and hinder the implementation of such frameworks, the authors could explore additional studies or literature that discuss specific facilitators and barriers.This could include factors such as organizational support, stakeholder engagement, resource availability, training and capacity building, cultural considerations, leadership buy-in, and financial constraints, among others.
In the background section, the authors initially mentioned that mental disorders are burdensome, but they did not specify such mental disorders and their prevalence.To address this, the authors can include relevant statistics or research findings that highlight the prevalence and impact of specific mental disorders, such as major depressive disorder, on a global scale.They could elaborate on how these disorders contribute to the burden by discussing their effects on quality of life, disability-adjusted life years (DALYs), or quality-adjusted life years (QALYs), and other relevant measures.
Moreover, to establish a connection between mental disorders and the achievement of sustainable development goals (SDGs), the authors could provide evidence or references that demonstrate how mental disorders act as barriers to the attainment of SDGs.They can explore studies or reports that showcase the impact of mental health issues on various dimensions of sustainable development, such as poverty reduction, education, gender equality, economic productivity, and social cohesion.This would strengthen the justification for the importance of addressing mental disorders within the context of the SDGs.
Considering that the study was conducted at the global level, it is essential for the authors to provide information on the implementation of evidence-based mental health interventions (EBmhIs) in different types of countries, including low-and middle-income countries, high-income countries, and middle-income countries.They should explain whether EBmhIs are well-known and widely implemented in these countries, and if not, what are the obstacles and barriers hindering their implementation.
More literature on conceptualisation of organisational readiness for change is needed.
How is your study different from the previous studies especially scoping review, systematic and metaanalyses studies?What is the novelty of your study?
I observe that the authors describe a theory of organisational readiness for change, which refers to an organizational-level construct referring to "organizational member's shared resolve to implement a change (change commitment) and shared belief in their collective capability do to do (change efficacy)."So, I think that the authors have to clarify more details about organisational reediness change.They also have to critique available instruments for measuring organizational readiness for change as having "limited evidence of reliability and validity." The rationale is the justification for undertaking a study in a particular population and areas of interest.Based on the information provided by the authors in the subheading "rationale", the text provided seems unclear for me or the text does not fit in the subheading.So, I can suggest the authors to remove the subheading or strengthen rationale by explain the reason why they conduct this scoping study (clarifying a research gap and justification).
Objective: The research questions do not cover well the EBmhIs, can this be clarified if they are different from RFC?

Methods:
The study was conducted in on EBmhIs which is mental health domain.This indicates that there many databases such as MEDLINE, Scopus, EBSCO, Science Direct, Embase, CINAHL, PubMed, Web of Sciences, PsycInfo, Cochrane, Web of Science, and Maestro and in ProQuest which are appropriate to find potential studies.But the authors selected only 4 databases.Why do you not include these databases which have many publications on mental health?

Search strategy:
The terms used to select potential studies for scoping review are not enough.This is because the readiness for change is related to several terms such as openness to change, attitudes or behaviors toward change, commitment to organisational change.
On page 4, the authors said that "Letters to editors, commentaries, theoretical articles, conference presentations, and chapters in textbook will be excluded", please, you have to explain why you excluded them.This is helpful for the readers.
Discussion: In the discussion section you say that the results will help to "identify and provide a rationale for the most important levels at which RFC may be measured depending on the setting".It is not completely clear to me how the review will answer this question.Do you mean at which levels it has been most frequently measured in different settings?I think that you should provide the following information; (1) expected strengths and limitations, and (2) public health implications / recommendations to the further research.

Minor errors:
Please, on page 2 (line 1 and line 2), you cannot use subheading at the start of your main text "background and introduction".Rationale for the area of study: The authors say that research regarding RFC in EBmhIs contexts is limited.Thus, the proposed review aims to address this issue and fill existing knowledge gaps regarding RFC's conceptualisation, operationalisation, and impact in EBmhIs.The rationale is sound and is consistent with the proposed review's outlined objectives, which are communicated clearly.
Method: A scoping review method will be used (which is appropriate for an exploratory study like this) and will appropriately be guided by the PRISMA ScR guidelines.The outlined protocol has done a good job of structuring the scoping review in line with these guidelines.Additional methodological guidance from established scoping review frameworks (e.g., Arksey & O'Malley, 2005 1 ; Peters et al., 2020 2 ) could also be useful and is worth consulting if this hasn't been done.Having said this, adherence to these frameworks is not essential as the PRISMA ScR is comprehensive and informed by them anyway.The eligibility criteria should contain details on the publication year range that will be included (if any).
There should be a brief rationale for why grey literature (e.g., letters to editors) is not to be included.
The eligibility criteria list is partly informed by the PICO framework.This is not incorrect, but it is also worth considering how the PCC (Population, Concept, Context) framework might influence the criteria.The PCC model is recommended for scoping reviews by the Joanna Briggs Institute.Some detail could be added to explain things more clearly in the Selection Process section.Adding a PRISMA flowchart outlining the process might make things clearer.
Medical Management Centre, Karolinska Institutet, Stockholm, Sweden Thank you for the opportunity to review this scoping review protocol.The proposed review will scope the scientific literature on the conceptualization and measurement of readiness for change for implementation of EBmhIs across organizational, group, and individual levels.The study protocol is outlined according to the Prisma-Scr and the authors provide a clear description of the planned methods that will be used in the different stages in the review process.I have some minor comments and suggestions.Discussion: In the discussion section you say that the results will help to "identify and provide a rationale for the most important levels at which RFC may be measured depending on the setting".It is not completely clear to me how the review will answer this question.Do you mean at which levels it has been most frequently measured in different settings?Reviewer Expertise: implementation science I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Figure 1 .
Figure 1.PRISMA Flow Diagram Adapted to Explain Our Selection Process.

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You need a reference on page 2 at the end of the first of the first paragraph / in the background.○Please,provide a reference at the end of the second paragraph of the background.○Beforeyou start using PRISMA, please, provide its full words.○Isthe rationale for, and objectives of, the study clearly described?NoIs the study design appropriate for the research question?YesAre sufficient details of the methods provided to allow replication by others?PartlyAre the datasets clearly presented in a useable and accessible format?PartlyCompeting Interests: No competing interests were disclosed.Reviewer Expertise: Mental health, Family health, Parenting, Child health, Occupation scienceI confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.Reviewer Report 30 June 2023 https://doi.org/10.21956/wellcomeopenres.20628.r59101Aim:Thestudy aims outlines a protocol for a scoping review.The proposed scoping review aims to examine literature on the concept of Readiness for Change (RFC) as it relates to evidence-based mental health interventions (EBmhIs).

Background:
Weiner et al have conducted a review of the literature around the conceptualization and measurement of organizational readiness for change in 2008.Although it is now quite old and not limited to mental health, I recommend that you mention it in your protocol and/or in your scoping review with description about how your review differ from/add to this review.(Weiner BJ, Amick H, Lee SY.Conceptualization and measurement of organizational readiness for change: a review of the literature in health services research and other fields.Med Care Res Rev. 2008 Aug;65(4):379-436 1 ) Objective: It is not completely clear what type of impact you will assess in RQ3, can this be clarified?Search strategy: There may be other terms that have been used to describe readiness for change, e.g.readiness for organizational change(Armenakis et al., 1993 2 ), organizational readiness for change(Weiner et al., 2008) which you should be able to capture with your suggested search strategy.My question concerns other related terms such as commitment to organizational change(Herscovitch & Meyer, 2002 3 ; Michaelis, Stegmaier, & Sonntag, 20104 ), receptivity to change(Frahm & Brown, 2007 5 ) and attitudes toward change(Elias, 2007 6 ; Lines, 2005 7 ) or openness to change.These constructs have sometimes been used interchangeably with readiness for change and you may want to consider adding related terms to the search strategy.

7.
Lines R: How social accounts and participation during change affect organizational learning.Journal of Workplace Learning.2005; 17 (3): 157-177 Publisher Full Text Is the rationale for, and objectives of, the study clearly described?Yes Is the study design appropriate for the research question?Yes Are sufficient details of the methods provided to allow replication by others?Yes Are the datasets clearly presented in a useable and accessible format?Not applicable Competing Interests: No competing interests were disclosed.